The X-ray Laboratory at the Industrial University of Santander (UIS) has consolidated its position as the only laboratory in Colombia with Good Laboratory Practice (GLP) certification from the National Institute for Food and Drug Surveillance (Invima) to perform X-ray diffraction analysis, after obtaining the renewal of this technical recognition.
This endorsement from the country’s highest drug regulatory body represents a guarantee of reliability for the pharmaceutical industry, as it supports the quality, traceability, and scientific rigor of the analyses performed and offers companies results with high standards and national and international recognition. This certification was made possible thanks to the support of the Vice-Rector’s Office for Research and Extension (UIS).
X-ray diffraction is a fundamental technique for the pharmaceutical industry, as it allows the crystalline structure of solid substances to be analyzed, the purity of active ingredients, raw materials, and medicines to be verified, and confirmation that products maintain the pharmacological activity necessary to guarantee their efficacy and safety.
According to Nelsy Pilar Vázquez Torres, technical director of the X-ray Laboratory’s Pharmaceutical Line, this certification endorses the quality of the services offered by the University to the industry.
“This accreditation recognizes us as the only laboratory in the country that has Invima’s endorsement to perform X-ray diffraction analysis. Invima is the regulatory body for the pharmaceutical industry in Colombia, so our clients can be certain that the results we deliver are reliable, unambiguous, and obtained by expert professionals with more than ten years of experience,” she explained.
The scope of the accreditation includes physicochemical analysis using the X-ray diffraction technique, as well as testing and validation studies of analytical methodologies and compendial verification, key services for quality control and product development processes in the industry.
“In a drug, X-ray diffraction allows us to identify whether the crystalline form present is the one that actually has pharmaceutical activity and whether the compound meets the required purity standards. This is key to ensuring that the final product, for both human and veterinary use, is safe and effective. This achievement accredits us as a strategic ally for the pharmaceutical industry in the structural analysis of active ingredients, drugs, and products,” said Vázquez Torres.
For his part, José Antonio Henao Martínez, director of the X-ray Laboratory and professor at the UIS School of Chemistry, emphasized that the renewal of this certification strengthens industry confidence in the specialized services offered by the University.
“Having this Invima certification again allows us to continue performing physicochemical analyses of active ingredients, finished products, semi-finished products, and even packaging materials, ensuring that these analyses are certified and reliable for companies that require technical and regulatory support,” he said.
In addition to providing services to domestic companies, the laboratory also supports international companies in studies related to patents, polymorphism analysis, and diffraction patterns, expanding its reach as a strategic partner for research, development, and innovation in the pharmaceutical industry. The certification granted by Invima also opens up the possibility of moving toward new accreditations, such as certification in Good Laboratory Practices with the Colombian Agricultural Institute (ICA), the regulatory body for the veterinary and agricultural sector. This will allow for expanding the impact of these services in industries related to veterinary medicines, food, and agricultural products.
